Posting Date: 29–Apr–2011
Official Date: 01–May–2011
Expert Committee: Monographs—Small Molecules 3
Reason for Revision: Compliance
In accordance with the Rules and Procedures of the 2010-2015 Council of Experts, the Monographs-Small Molecules 3 Expert Committee has revised the Mycophenolate Mofetil Capsules monograph. The purpose for the revision is to widen the acceptance criteria under Organic Impurities, to accommodate the sponsor's FDA-approved specifications:
- Increase the limit of mycophenolic acid from NMT 0.7% to NMT 1.0%
- Increase the limit of total degradation products from NMT 1.0% to NMT 1.5%
The Mycophenolate Mofetil Capsules Revision Bulletin supersedes the currently official monograph. The Revision Bulletin will be incorporated in USP 35-NF 30.
Should you have any questions, please contact Feiwen Mao (301-816-8320 or fm@usp.org).